This invention relates to methods of verifying the identity and determining the concentration, potency, purity and presence of contaminants, including, but not limited to, microbial, endotoxins and particulate matter in a mixture of ingredients on site in a healthcare facility, pharmacy, home care situation, pharmaceutical manufacturing facilities and other sites, as well as series of integrated devices, systems and processes for the analysis, organization, monitoring and reporting of such analyses and related metadata through an electronic network.
Pharmacies generally compound pharmaceuticals that are not readily available on the market, for example, but not limited to, specialized dosage forms, certain oncological formulations, pediatric formulations, certain ophthalmic preparations, intravenous solutions, or other compounded pharmaceuticals referred to as compounded sterile preparations (“CSPs”). In the past, the pharmacists generally followed good compounding practices mandated by federal and state pharmacy practice acts and accepted professional compounding techniques. However, these CSPs have not been subject to concentration and purity guidelines set forth by the United States Food and Drug Administration (“FDA”) or other regulatory bodies. If a compounding pharmacy wanted to analyze a product for potency or purity, it was required to engage outside testing laboratories that employed traditional analysis such as chromatography or other analytical procedures to test the individual CSPs. These processes are costly and time consuming and employed only on a limited basis.
It recently has been determined that some pharmacies have failed to meet the concentration guidelines set forth by the prescribing physician, or have produced pharmaceuticals having impurities, microbial, endotoxin and particulate matter. In response, the regulatory bodies have set forth guidelines requiring that extemporaneous CSPs prepared under high-risk conditions be tested for concentration and purity prior to distribution to ensure the safety of the pharmaceutical for public use. Moreover, it is anticipated that in the future, regulatory bodies will set forth compounding guidelines for all CSPs, regardless of risk.
While the guidelines set forth by the regulatory bodies have resulted in safer and more reliable CSPs, the testing of each batch or individual CSP using traditional physical analyses has resulted in a loss of time and financial resources for the pharmacies. Furthermore, traditional physical analysis takes time and is not necessarily useful in emergency situations.
Also, the need often arises for a CSP or other admixed compound to be extemporaneously prepared at or near the time for administration, leaving little time for conventional analysis of the product. For example a physician or nurse may be required to compound a product in a patient care area.
Therefore, there is a need for methods and systems, including procedures, hardware and software, for testing CSPs and other admixed compounds that avoid the expense, time and other problems associated with the use of traditional physical analyses for testing CSPs. It would be advantageous to have such methods and systems that allow for the testing on-site, for example in patient care areas of healthcare facilities, at a pharmacy where the CSP is prepared or both. In facilitating such a method, it would be advantageous to have an instrument for performing at least part of such analysis that is fully functional, but small enough to be portable or even handheld and uses only a small sample volume.